Compliance Specialist, Combination Product Operations

Rensselaer, NY, United States
Mar 21, 2019
Required Education
Bachelors Degree
Position Type
Full time
Known for its scientific and operational excellence, Regeneron is a leading science-based biopharmaceutical company that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for eye diseases, high LDL-cholesterol, atopic dermatitis and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including rheumatoid arthritis, asthma, pain, cancer and infectious diseases.

Summary: Leads compliance-related activities, such as document creation, Change Controls, CAPA, Change Notifications, Deviation investigations, etc. across all functional areas within Delivery Systems and Drug Product Engineering.

Essential Duties and Responsibilities include, but are not limited to, the following:

• Ensures that all activities related to document creation are performed in a timely manner in and in compliance with Regeneron procedures and regulatory requirements.

• Leads and manages investigation related to process variances involving aseptic filling, container closure materials and manufacturing, and delivery device performance and manufacturing.

• Maintains an organized record of compliance-related items and provides periodic status updates to the Combination Product department

• Ensures Corrective & Preventative Actions are appropriate, are implemented as planned and have the intended effectiveness.

• Ensures that all Change Control and Change Notification activities are performed in a timely manner and in compliance with Regeneron procedures and regulatory requirements.

• Keeps team members informed of the status of assigned work.

• Identifies recurring events and ensures appropriate actions are taken, such as Management notification.

• Additional responsibilities, as determined by management

• Functions as Project Lead for a cross-functional team to complete impact assessments associated with compliance-related items

Knowledge, Skills & Abilities:

• Ability to maintain integrity and honesty at all times

• Ability to work independently or as part of a team

• Ability to communicate with transparency

• Continuously drive to improve processes for improved performance

• Demonstrate respectful behavior at all times

• Ability to multi-task

• Ability to analyze and identify trends

• Develops and delivers effective presentations

• Problem-solving skills

• Ability to train others on basic systems and processes

• Strong written communication

• Ability to work in an ever-changing environment

• Critical thinking skills

Education and Experience:
Requires Bachelor's Degree in chemistry, biology, engineering, or a related field with two or more years of experience in leading investigations/change controls in a cGMP environment. Will consider Bachelor's degree in other discipline with relevant experience. Project Management skills preferred.

This is an opportunity to join our select team that is already leading the way in the Pharmaceutical/Biotech industry. Apply today and learn more about Regeneron's unwavering commitment to combining good science & good business.

To all agencies: Please, no phone calls or emails to any employee of Regeneron about this opening. All resumes submitted by search firms/employment agencies to any employee at Regeneron via-email, the internet or in any form and/or method will be deemed the sole property of Regeneron, unless such search firms/employment agencies were engaged by Regeneron for this position and a valid agreement with Regeneron is in place. In the event a candidate who was submitted outside of the Regeneron agency engagement process is hired, no fee or payment of any kind will be paid.

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability status, protected veteran status, or any other characteristic protected by law.